Examining the Effect of Minimal Plastics Exposure on Plastic-Associated Chemicals (PAC) Excretion and Biomarkers in Adults With Cardiometabolic Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in bisphenols (composite of bisphenol A, BPA; and bisphenol S, BPS)
研究概览
简要总结
The goal of this randomized controlled trial is to learn if an intervention of reducing plastic exposure through diet, personal care and cleaning products can improve health outcomes in adult participants with cardiometabolic risk factors. The main questions it aims to answer are:
- Will the low plastic exposure intervention reduce urinary excretion of bisphenols?
- Will the low plastic exposure intervention reduce urinary excretion of phthalate metabolites?
- Can reducing plastic exposure improve cardiometabolic biomarkers?
Researchers will compare this 4-week low plastic intervention with a control/no intervention group.
Participants in the intervention group will:
- be provided with food that have no/low plastic and plastic-associated chemicals
- be provided with personal care and cleaning produces that have no/low plastic and plastic-associated chemicals
- replace cooking and food preparation equipment with no/low plastic alternatives
Participants in the control group will not receive the intervention and are not expected to change their behaviour.
All participants will provide biological samples (urine, stool, nasal lavage and blood) at several timepoints during the study and attend 4 clinic visits: screening and before, during and after the intervention. Participants will also complete the sociodemographic questionnaire, a physical activity assessment using the International Physical Activity Questionnaire (IPAQ - Short Form), the 24-hr personal care product recall questionnaire, the plastic-associated chemicals questionnaire and be interviewed by a member of the research team to complete a 24-hour diet recall (24DR-PE) of food consumed, and how it was stored prepared, and consumed. The 24DR-PE will facilitate assessments of deviations from the protocol, and enable the assessment of energy, macro and micronutrient intake.
详细描述
Many plastic products contain endocrine disrupting chemicals, such as bisphenols and phthalates (referred to as plastic-associated chemicals or PAC), which leach out from everyday use and enter the human body. Food contaminated from packaging or with plastic particles, personal care and cleaning products may be sources of PAC which can be inhaled or absorbed through the skin. The fundamental premise underpinning the research is that exposure to PAC, combined with genetic and lifestyle factors, creates chronic and systemic inflammation that underpins cardiometabolic conditions.
This randomized controlled trial aims to demonstrate whether decreasing exposure to plastic and PAC will reduce urinary excretion of PAC and improve cardiometabolic biomarkers in people with cardiometabolic risk factors.
Participants that have consented and passed health screening (N=60) will be randomized to one of two parallel groups, to receive a 4-week low plastic intervention in their homes with the support of registered dietitians.
- Group 1 (N=30): low plastic intervention group
- Group 2 (N=30): control/no intervention group
All participants will attend four in-person clinic appointments, one during screening, and three during the intervention (Visit 1: day 0, baseline; Visit 2: day 16, midpoint; and Visit 3: day 29, post intervention), of up to two hours duration each. In addition, participants will have a video/phone appointment between screening and Visit 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The statisticians and laboratory personnel involved in analysis of the biological samples will be blinded to participant status
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Biological males or, non-pregnant, non-lactating biological females aged 18 to 60 years.
- •a) For female participants at least one of the following must apply: i) Not of childbearing potential - surgical sterile or postmenopausal (no menses last 12 months and follicle-stimulating hormone (FSH) greater than 40 mIU/mL); ii) Childbearing potential and agrees to practice true abstinence, is in a same-sex relationship or agrees to use effective contraception during the study (either hormonal contraception, intrauterine devices or condom) or has a vasectomised male partner.
- •Body mass index ≥30 kg/m
- •If outside this range, eligible at investigator's discretion.
- •Waist circumference ≥102cm in men and ≥88cm in women. If outside this range, eligible at investigator's discretion.
- •Certain medications may be excluded based on investigators discretion.
- •Lives in the Perth Metropolitan Area.
- •Willing to change all they eat, not eat out and not wear makeup for 4 weeks if selected for intervention.
- •Ability to give written informed consent.
- •Proof of immunisation against COVID-19 (SARS-CoV-2), according to WA Health guidelines at time of recruitment.
排除标准
- •Any abnormalities in electrocardiogram (ECG) readings, or as per the Investigator's discretion.
- •History of drug or alcohol abuse in the past 24 months. Alcohol abuse defined as greater than 21 units/week for males, greater than 14 units/week for females.
- •Current regular smoker or e-cigarette use. Social smokers (less than 3 nicotine/tobacco products in the last 3 months) can be included if abstaining for the duration of the study.
- •Currently pregnant or planning pregnancy during the course of the study as assessed by pregnancy testing carried out during screening.
- •Currently on, or within 3 months of discontinuing, glucagon-like peptide-1 agonists or related compounds. If inside this range, eligible at Investigator's discretion.
- •Living in a home that has been renovated in the past 4-weeks.
- •Have known severe food allergies or anaphylaxis to common food allergens. As per the Investigator's discretion.
- •Not suitable for the study for any other reason, as determined by the investigator.
- •Acute infection, surgery, vaccination, or other inflammatory process in the previous 2 weeks. Minor procedures are exempt at investigator's discretion.
- •Evidence of moderate or greater renal impairment at screening, as indicated by an estimated creatinine clearance of less than 60 mL/min using the Cockcroft-Gault equation.
- •Clinically significant abnormal laboratory tests or examination findings, as determined by the investigator, not otherwise mentioned.
结局指标
主要结局
Change in bisphenols (composite of bisphenol A, BPA; and bisphenol S, BPS)
时间窗: Baseline and 4 weeks for both groups
Assessed by measuring urinary concentrations (ng/mL) of BPA and BPS and comparing mean percent change
次要结局
- Change in bisphenol A (BPA)(Baseline, and 1, 2, 3 and 4 weeks for both groups)
- Change in bisphenol S (BPS)(Baseline, and 1, 2, 3 and 4 weeks for both groups)
- Change in diethyl phthalate (DEP)(Baseline, and 1, 2, 3 and 4 weeks for both groups)
- Change in di-n-butyl-phthalate (DnBP)(Baseline, and 1, 2, 3 and 4 weeks for both groups)
- Change in di-iso-butyl phthalate (DiBP)(Baseline, and 1, 2, 3 and 4 weeks for both groups)
- Change in benzyl butyl phthalate (BBP)(Baseline, and 1, 2, 3 and 4 weeks for both groups)
- Change in di-(2-ethylhexyl) phthalate (DEHP)(Baseline, and 1, 2, 3 and 4 weeks for both groups)
研究者
Michaela Lucas
Professor
The University of Western Australia